The effective functioning of the human digestive process requires the coordinated secretion, delivery and action of a variety of chemical substances.
The stomach secretes gastric juice which is primarily an aqueous solution of hydrochloric acid and pepsin. The acid serves to chemically break down food particles, to activate pepsin, to stimulate pancreatic secretion and to aid iron absorption. Pepsin, a protein produced by the gastric glands, enzymatically digests protein to proteoses and peptones in acid medium, resulting in the further liquefaction of food and reduction of food particle size.
The fluid or semi-fluid stomach contents are then forced into the small intestine. Bile, pancreatic juice and intestinal juice are poured into the small intestine to complete the digestion of food begun in the mouth and stomach. Bile, delivered by the gall bladder, functions to emulsify, digest and to aid the gut absorption of the fatty acids resulting from the enzymatic hydrolysis of fats. Pancreatic juice contains enzymes for digesting proteins, carbohydrates and fats. Among the proteolytic enzymes are trypsin and chymotypsin, which break down larger protein fractions into peptides. Amylose converts starch into maltose and lipase splits fats into fatty acids and glycerin. The pancreas also secretes bicarbonate anions, which neutralize stomach acid and provide an appropriate pH (7-11) for the action of the pancreatic enzymes.
Digestive disorders resulting in the malabsorption of food components may arise from many causes. Cystic fibrosis, chronic pancreatitis, and pancreatic resection may lead to exocrine pancreatic insufficiency, which in turn is characterized by severe steatorrhea, or fecal fat excretion. Stomach cancer and resultant gastrectomy may also cause the disruption of pancreatic function, by reducing the acid secretion necessary for stimulation of pancreatic enzyme production.
Exocrine pancreatic insufficiency is commonly treated by the administration of pancreatic enzyme supplements, often in the form of enteric-coated preparations which resist degradation by stomach acid and pepsin. Other substances such as bile salts, additional proteolytic enzymes, cellulose, hemicellulose and simethicone may be included in varying amounts when the additional goal of treating postprandial abdominal distress symptoms is desired. These symptoms, which include bloating, pain, nausea, and excess intestinal gas production, may be pathological in origin or merely be due to dietary indiscretion or to "nervous indigestion". The composition of a number of these products and their modes of action has been described by D. Y. Graham, Enzyme Therapy of Digestive Disorders in Enzymes As Drugs, J. S. Holcenberg et al., eds., Wiley-Interscience (1981) at ch. 11.
Despite the numerous products which are, or have been available for the treatment of one or more of the above-described conditions, orally-administrable compositions designed to provide a unified attack on the entire spectrum of digestive disorder symptomology have not heretofore been described.
Therefore, it is an object of the present invention to provide compositions suitable for alleviation of digestive dysfunction due to pancreatic insufficiency, postprandial distress, and the like which are suitable for oral administration.
It is a further object of the present invention to provide compositions which effectively supplement the digestive substances present in both the stomach and small intestine.
Further objects, advantages, and novel features of the present invention will be apparent to those skilled in the art from the following description and appended claims.